65 FR 226 pgs. 70352-70354 - Pesticides; Elimination of Phenol Resistance Testing for AntimicrobialDisinfectant and Sanitizer Pesticides
Type: NOTICEVolume: 65Number: 226Pages: 70352 - 70354
Docket number: [OPP-00674; FRL-6736-9]
FR document: [FR Doc. 00-29895 Filed 11-21-00 8:45 a.m.]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-00674; FRL-6736-9]
Pesticides; Elimination of Phenol Resistance Testing for AntimicrobialDisinfectant and Sanitizer Pesticides
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice of availability.
SUMMARY:
The Agency seeks public comment on a draft PesticideRegistration (PR) Notice titled "Elimination of Phenol Resistance Testing forAntimicrobial Disinfectant and Sanitizer Pesticides." This draft notice providesguidance to registrants concerning the discontinuation of phenol resistance testing as a part ofefficacy testing for antimicrobial disinfectants and sanitizers.
DATES:
Comments, identified by docket control numberOPP-00674, must be received on or before January 8, 2001.
ADDRESSES:
Comments may be submitted by mail, electronically, orin person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION . To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00674 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
IbrahimBarsoum, Antimicrobials Division (7510C), Environmental Protection Agency, 1200Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-6417; faxnumber: (703) 308-8481; e-mail address: barsoum.ibrahim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. Although this action may be of particularinterest to those persons who manufacture or formulate pesticides. Potentially affectedcategories and entities may include, but are not limited to:
| Categories | NAICS | Examples of potentially affected entities |
|---|---|---|
| Pesticide Producers | 32532 | Pesticide manufacturers |
| Pesticide formulators |
Since other entities may also be interested, the Agency has not attempted to describe all thespecific entities that may be affected by this action. If you have any questions regarding theinformation in this notice, consult the person listed under FOR FURTHERINFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of this Document andOther Related Documents?
1. Electronically . You may obtain electronic copies of thisdocument and the PR Notice from the Office of Pesticide Programs' Home Page athttp://www.epa.gov/pesticides/. You can also go directly to the listings from the EPA InternetHome Page at http://www.epa.gov/. To access this document, on the Home Page select "Laws and Regulations," "Regulations and Proposed Rules," and then look up the entry for this document under the " Federal Register -EnvironmentalDocuments." You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. Fax-on-demand . You may request afaxed copy of the draft PR Notice titled "Elimination ofPhenol Resistance Testing for Antimicrobial Disinfectant and Sanitizer Pesticides,"by using a faxphone to call (202) 401-0527 and selecting item 6132. Youmay also follow the automated menu.
3. In person . The Agency has established an official recordfor this action under docket control number OPP-00674. The official recordconsists of the documents specifically referenced in this action, any public comments receivedduring an applicable comment period, and other information related to this action, including anyinformation claimed as confidential business information (CBI). This official record includes thedocuments that are physically located in the docket, as well as the documents that are referencedin those documents. The public version of the official record does not include any informationclaimed as CBI. The public version of the official record, which includes printed, paper versionsof any electronic comments submitted during an applicable comment period, is available forinspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, CrystalMall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703)305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. Toensure proper receipt by EPA, it is imperative that you identify docket control numberOPP-00674 in the subject line on the first page of your response.
1. By mail . Submit your comments to: Public Informationand Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C),Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460.
2. In person or by courier . Deliver your comments to:Public Information and Records Integrity Branch (PIRIB), Information Resources and ServicesDivision (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm.119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB isopen from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIBtelephone number is (703) 305-5805.
3. Electronically . You may submit your commentselectronically by E-mail to: opp-docket@epa.gov, or you can submit a computerdisk as described above. Do not submit any information electronically that you consider to beCBI. Avoid the use of special characters and any form of encryption. Electronic submissionswill be accepted in Wordperfect 6.1/8.0 file format or ASCII file format. All comments in electronicform must be identified by docket control number OPP-00674. Electroniccomments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. Youmay claim information that you submit to EPA in response to this document as CBI by markingany part or all of that information as CBI. Information so marked will not be disclosed except inaccordance with procedures set forth in 40 CFR part 2. In addition to one complete version ofthe comment that includes any information claimed as CBI, a copy of the comment that does notcontain the information claimed as CBI must be submitted for inclusion in the public version ofthe official record. Information not marked confidential will be included in the public version ofthe official record without prior notice. If you have any questions about CBI or the proceduresfor claiming CBI, please consult the person identified under FOR FURTHERINFORMATION CONTACT .
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that supportyour views.
4. If you estimate potential burden or costs, explain how you arrived at theestimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identify the docket control numberassigned to this action in the subject line on the first page of your response. You may alsoprovide the name, date, and Federal Register citation.
II. Background
A. What Guidance Does this PR Notice Provide?
The draft PR Notice announces the discontinuation of phenol resistance testing asa part of efficacy testing for antimicrobial disinfectants and sanitizers. When the PR Notice isissued in final form, the Agency will consider registering or reregistering antimicrobialdisinfectant or sanitizer pesticides without supporting phenol resistance testing. All other datain support of registration or reregistration, including any required efficacy testing data, wouldalso need to be submitted and then accepted by the Agency.
Phenol resistance testing is a standard that has traditionally been used to estimate theintrinsic resistance or sensitivity of some test bacteria to chemical disinfectants and sanitizers.For years, the Agency has been aware of the lack of standard and uniform resistance levels tophenol expressed by the test cultures used in the existing Official Methods of Analysis of theAssociation of Official Analytical Chemists (AOAC) test methods. Historically, the inability tomaintain and propagate test cultures that express standard and uniform levels of phenolresistance has been a recognized scientific problem which has persisted for at least 70 years.Furthermore, the inability of many reputable and competent testing facilities to achieveconsistent test results with the phenol resistance standard has prompted both concern and actionby the Agency.
On September 10, 1997, after internal scientific deliberation, the Agency placed beforethe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel(SAP) the following questions regarding phenol resistance:
What scientific direction should be taken regarding the lack of standard anduniform resistance levels to phenol of the test cultures used in the existing AOACefficacy test methods? Should theAgency:
•Totally eliminate the phenol resistance requirement; or
•Modify the required phenol resistance patterns to provide a broader range ofacceptable resistance; or
•Replace the phenol resistance requirements with some other procedures thatassure hardiness and equivalence to test cultures, such as standard, quantitativeinoculum level?
Briefly, the SAP responded that there is no current relevance to requiring the phenolresistance test and, therefore, the phenol coefficient method should be eliminated and newprotocols should be established for defining the conditions for culturing test microorganismswith suitable resistance levels to antimicrobials.
Subdivision G of the Pesticide Assessment Guidelines, part 91-1, describes the generalproduct performance (efficacy) standards for disinfectants and sanitizers. Subsection (b)(3)(I) ofpart 91-1 refers to the AOAC standard tests that may be used to satisfy the data requirements of40 CFR 158.640. In turn, these AOAC tests include references to phenol resistance testing.
The Agency concurs with the SAP and has engaged in considerable discussion anddeliberation, internally and with members of the scientific and regulated communities, on howto best proceed. Given the inapplicability of a test organism's resistance to phenol whendisinfectants or sanitizers are tested for their efficacy performance, the Agency will no longerrequire submission of testing to demonstrate compliance with AOAC specified levels ofexpressed phenol resistance by test microorganisms during the efficacy evaluation ofdisinfectants or sanitizers. However, as an interim measure while method development research continues, the Agency generally will expect a minimum inoculum level of 10 4 colony forming units per carrier for all test microorganisms when the AOAC carrier based tests are used.
B. PR Notices are Guidance Documents
The draft PR Notice discussed in this notice is intended to provide guidance toEPA personnel and decision-makers and to pesticide registrants. This notice is not binding oneither EPA or pesticide registrants, and EPA may depart from the guidance where circumstanceswarrant and without prior notice. Likewise, pesticide registrants may assert that the guidance isnot appropriate or not applicable to a specific pesticide or situation.
List of Subjects
Environmental protection, Administrative practice and procedure, Agriculturalcommodities, Pesticides and pests.
Dated: November 9, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-29895 Filed 11-21-00 8:45 a.m.]
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